FDA to make painkillers less potent due to liver damage risk

FDA to make painkillers less potent?

Painkillers linked to liver damage must be made with less acetaminophen according to the U.S. Food and Drug Administration. The health agency said Thursday that it will set limits of the key ingredient at 325 milligrams per capsule of such brands as Percocet and Vicodin because hundreds of cases of liver damage have been reported from the use of such medications.

Acetaminophen is a common ingredient of pain relievers like Tylenol and many other drugs used to treat fever, headache and sore throats. Prescription drugs also contain the ingredient mixed with narcotics like oxycodone.

Health officials clarified that the drugs do not pose an inherent risk but their effects may be dangerously multiplied and cause an overdose if people take an additional pill containing acetaminophen. In other words, multiple sources of acetaminophen can be toxic.

FDA noted that prescription labels seldom disclose that a drug contains acetaminophen and manufacturers just use abbreviations such as "APAP" instead.

"One of the real challenges we have is that patients taking these products don't know they're taking acetaminophen at all," said Sandra Kweder, who is the agency's director for new drugs. "They don't realize that they are overdosing."

Health officials said they will be coordinating with pharmacies to come up with a clear, uniform labeling for acetaminophen-containing products. The FDA assured the public that the painkillers in the market will retain their effectiveness.

"The amount of acetaminophen in these products has gradually crept up over the years," Kweder said. "If you look at these products 20 to 30 years ago, many did not contain high doses of acetaminophen."

Over-the-counter painkillers like Tylenol and Theraflu are not covered by the FDA's order. They are still allowed to contain a maximum of 500 milligrams of acetaminophen per capsule.

Posted by George Daniels on Saturday January 15 2011, 2:59 AM EDT. Ref: AP. All trademarks acknowledged. Filed under Featured News, Health. Comments and Trackbacks closed. Follow responses: RSS 2.0